(b) proof of qualification of medical device manufacturers: including the manufacturer's license, copy of the business license; the declared products should be within the scope of the license approved production;
(c) product technical reports; at least should include the technical indicators or the main performance requirements of the determination of the basis of the contents;
(d) safety Risk management report; prepared in accordance with the requirements of YY0316 "medical device risk management" standard. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and hazards caused by functional failure, poor maintenance and aging and other five aspects of the analysis and the corresponding preventive measures.
(E) national standards, industry standards or registered product standards and instructions. Adoption of national standards, industry standards as the applicable standards of the product, should provide the product applied for in line with national standards, industry standards, and bear the responsibility for the quality of the product on the market after the statement of the quality of the product and the relevant product model, specifications division of the description, the submission of adopted national standards or industry standards of the text. Registered product standards should be commissioned by the manufacturer or producer to draft standards for the unit signed. Production enterprises commissioned to draft standards should be noted in the commission "product quality by the manufacturer is responsible for".
(F) product performance self-test report; product performance self-test project for the registered product standards in the factory testing program, there should be the main inspection, audit signature. If the enterprise implementation of national standards and industry standards, should be supplemented with self-defined factory test items.
(VII) the State Food and Drug Administration recognized medical device testing organizations issued by the product registration test report; need to conduct clinical trials of medical devices, should be submitted to the start of clinical trials within six months prior to the issuance of the test report. Do not need to conduct clinical trials of medical devices, should be submitted to the registration acceptance within one year before the issuance of the test report. Implementation of the provisions of Article 11, Article 12, Article 13, Article 14, shall provide the corresponding documents.
(viii) more than two clinical trial sites of clinical trial information;
(ix) product instructions;
(x) product quality system assessment (certification) of valid documents; according to the requirements of different products, provide the appropriate quality system assessment report: 1, the provincial people's government (Food) and Drug Administration signed, within the validity period of the system assessment report; 2, the provincial people's government (Food) and Drug Administration signed; the system assessment report; and Within the system assessment report; 2, medical device production quality management standard inspection report, or medical device quality system certification; 3, the state has implemented the implementation of production rules, the implementation of the rules submitted to the inspection and acceptance report;
(k) the authenticity of the materials submitted to the self-assurance statement. Should include a list of materials submitted, the production company's commitment to assume legal responsibility. Procedures: